NCT03140462

Brief Summary

To study the influence of donor's ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on tacrolimus blood concentration in liver transplant recipients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

May 21, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2018

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 11, 2021

Status Verified

December 1, 2020

Enrollment Period

11 months

First QC Date

April 24, 2017

Last Update Submit

August 4, 2021

Conditions

Liver Transplantation

Keywords

TacrolimusPharmacokineticsGenetic polymorphisms

Outcome Measures

Primary Outcomes (1)

  • Dose normalized trough concentration of tacrolimus in liver transplant patients within the first 6 months post-transplantation

    Analyse the effect of the donor's genetic polymorphism to dose normalized trough concentration of tacrolimus in liver transplant patients. Trough level of tacrolimus was adjusted by liver recipient's body weight.

    Within the first 6 months post-transplantation

Study Arms (1)

liver transplant patients and donors

To study clinical and genetic factors on tacrolimus dose normalized trough concentration.

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

liver transplant patients' donors

You may qualify if:

  • Living liver transplant during 20070101 \~ 20151231 and only received liver transplantation
  • Lab data at least 8 months,
  • Receiving tacrolimus as immunosuppressive drugs
  • Transplantation at 20 \~ 65 years old

You may not qualify if:

  • Retransplantation or multi-organ transplantation
  • Non-Asian
  • Positive for human immunodeficiency virus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan University Hospital

Taipei, 10050, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood , paraffin-embedded liver biopsy, or saliva

Study Officials

  • Rey-Heng Hu

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2017

First Posted

May 4, 2017

Study Start

May 21, 2017

Primary Completion

April 12, 2018

Study Completion

December 31, 2020

Last Updated

August 11, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)